KR20060035779A - Masticatable capsule and process for producing the same - Google Patents

Abstract

Masticatable capsules comprising a capsule wall membrane and, sealed therein, contents, wherein the capsule wall membrane has an outside diameter of 14 to 25 mm and has a mass of 10 to 20% based on the total mass of masticatable capsule while the amount of contents sealed in the capsule wall membrane is in the range of 1400 to 3000 mg, and wherein the capsule wall membrane contains gelatin.

Description

Masticatable capsule and process for producing same

The present invention relates to capsules suitable for chewing, so-called chewable soft capsules and methods of making the same.

This application claims priority to Patent Application No. 2003-284072 filed on July 31, 2003, the content of which is incorporated herein.

As a prior art regarding the soft capsule which contains gelatin as a capsule film composition, and its manufacturing method, following patent document 1-patent document 5 are known, for example.

Patent Document 1: Japanese Patent Application Laid-Open No. 2001-89362

Patent Document 2: Japanese Patent Laid-Open No. 10-273436

Patent Document 3: Japanese Patent Application Laid-Open No. 2001-161306

Patent Document 4: Japanese Patent Application Laid-Open No. 2000-136127

Patent Document 5: Japanese Patent Application Laid-Open No. 11-266804

Patent Literature 1 (encapsulated particulate matter and its manufacturing method, Sansho Pharmaceutical Co., Ltd.) relates to reducing adhesion of soft capsules by saccharide deposition such as xylitol blended into gelatin coating. . Example 1 describes a method for producing a soft capsule using a method of forming a capsule solution containing gelatin into a capsule shape while filling the contents, solidifying and rotating drying.

Patent document 2 (the soft capsule for operation, Tokai Capsule Co., Ltd.) relates to softening a gelatin film by mix | blending a plasticizer, and reducing adhesiveness of soft capsules by mix | blending crystalline cellulose.

Patent document 3 (the gelatin capsule manufacturing method excellent in preference, Esaki Glico Co., Ltd.) relates to improving the flavor of a soft capsule by containing an emulsifying fragrance in a gelatin film with high efficiency.

Patent document 4 (fast-soluble soft capsule, Sansho Pharmaceutical Co., Ltd.) has a water content of 15% to 80% of the soft capsule film and a soft capsule film mass of 10% to 70% of the total mass of the soft capsule. The present invention relates to a soft soft capsule having a very fast dissolution of the coating.

Patent document 5 (royal jelly oily suspension and royal jelly capsule, Sansho Pharmaceutical Co., Ltd.) relates to the royal jelly oily suspension which suppressed discoloration, and the royal jelly soft capsule which contained 450 mg as a content.

In addition, Patent Document 6 (highly acidic disease preventing therapeutic agent, Morinaga Dairy Co., Ltd.) contains 20 carbon atoms and / or derivatives thereof, and monocarboxylic acid and / or derivatives thereof having 22 carbon atoms as an active ingredient. It relates to a hyperuric acid disease preventive treatment. One example of a dosage form is a capsule.

Patent Document 6: Japanese Patent Application Laid-Open No. 2001-278786

In the preparation of chewable chewable capsules, it is required to make the coating soft enough to be chewed and large enough to be swallowed as it is. In addition, it is important that the taste is good when eaten because the amount of the content is large.

However, it is difficult to manufacture this type of capsule and it is not yet realized. For example, it has been difficult to mold a conventional soft capsule relatively large so that it cannot be swallowed while keeping it in a chewable physical state (hardness, etc.). In addition, attempting to increase the amount of the contents has a problem that self-deformation and self-destruction destroy easily occur during manufacturing.

This invention is made | formed in view of such a situation, and an object of this invention is to provide the capsule suitable for chewing, and its manufacturing method.

MEANS TO SOLVE THE PROBLEM As a result of earnestly examining in order to solve the said subject, the present inventors discovered that the capsule which is large and large in content, the film is soft by the following structure, and was able to manufacture with good chewability came to complete this invention.

That is, the chewable capsule of the present invention includes a capsule film and the contents encapsulated in the capsule film, and has the following properties a), b), c) and d).

a) the outer diameter of the capsule coating is 14 mm to 25 mm,

b) the mass of the capsule coating is in the range of l0% to 20% relative to the total mass of the capsule,

c) the amount of the contents encapsulated in the capsule film is 1400 mg to 3000 mg,

d) the capsule coating contains gelatin.

It is preferable that the said capsule film contains 30-200 mass parts of glycerin and 1-200 mass parts of crystal precipitation agents with respect to 100 mass parts of gelatin.

It is preferable that at least one part of the said crystal precipitation agent is exposed to the film surface as a crystal | crystallization.

It is preferable that the said content is a liquid lipophilic substance which has a viscosity of 2 Pa * s or less at 25 degreeC.

The contents preferably contain one or two or more selected from the group consisting of animal and vegetable oils, phospholipids and ceramides.

Alternatively, the contents may contain at least one member selected from the group consisting of monocarboxylic acid and / or derivatives thereof having 20 carbon atoms, and at least one member selected from the group consisting of monoenoic acid having 22 carbon atoms and / or derivatives thereof. It is preferable.

The manufacturing method of the chewable capsule of this invention is a method of manufacturing the chewable capsule of this invention, The process of forming a capsule-shaped molded object using the coating material liquid containing gelatin, and the drying process of drying the said molded object. In the drying process, for the first condition selected in the range of humidity 30% to 50%, temperature 20 ℃ to 30 ℃, the humidity is within ± 5%, the temperature is controlled within ± 2 ℃ Primary drying is carried out for 10 to 12 hours, and after the primary drying, aging is performed for 2 hours to 3 hours in a controlled atmosphere within a range of humidity 70% ± 5% and a temperature of 25 ° C ± 2 ° C. Humidity is within ± 5% and temperature is within ± 2 ° C for the second condition selected within the range of 30% to 50% of humidity, 20 ° C to 30 ° C for 2 to 35 hours in a controlled atmosphere. It is characterized by drying tea.

According to the present invention, a chewable capsule, which is too large to be swallowed, has high strength even though a thin film is thin, is easy to chew and can be eaten deliciously.

According to the chewable capsule manufacturing method of the present invention, after molding, by drying under specific conditions, a large, thin film is soft, and even if the amount of the content is large, high-quality chewable capsules can be produced by preventing deformation or destruction of self-weight. .

The chewable capsule of the present invention has a large outer diameter and has a low ratio of the film mass to the total mass of the capsule. Since the film is thin, the film melts quickly in the mouth, and there is no remaining feeling of the film. It is also a good size to eat.

Since the form is a capsule (double structure), the contents can be blended in a large amount compared to jelly or fruit. Since the contents are covered with a coating, oxidation of the contents is difficult to occur. High protective effect of the contents, good storage stability.

If xylitol crystals are exposed on the capsule surface, the freshness spreads in the mouth at the moment of eating. In addition, even if stored under high temperature, the adhesion between the capsules is suppressed. Good preservation

If the viscosity of the contents is 2 Pa · s or less at 25 ° C, the fluidity of the contents is good, and the components of the capsule contents easily spread in the mouth when ingested.

Best Mode for Carrying Out the Invention

In the present invention, the capsule coating outer surface shape is not particularly limited. For example, it can be made into various shapes, such as a substantially spherical shape, such as a sphere and an ellipsoid, approximately a cube, and a substantially rectangular parallelepiped. Preferably it is spherical or approximately spherical.

The outer diameter value of the capsule film in this specification is a maximum value of a long axis in the cross section through the center of the outer surface shape of a capsule film, and can be measured using a ruler, such as a vernier caliper, for example. Moreover, in the case of a sphere, it can also measure by general methods, such as volume conversion.

The chewable capsule of the present invention has an outer diameter of the capsule coating within the range of 14 mm to 25 mm. By setting it within this range, it is easy to eat, easy to chew, and spread | diffusion (diffusion property) of the content in the mouth at the time of eating can obtain a favorable texture.

The ratio of the capsule film mass to the total capsule mass is within the range of 10% to 20%. If the ratio is smaller than the above range, the breaking strength may be insufficient, or the contents may leak due to storage under high temperature or changes in environmental temperature. Moreover, when the said ratio exceeds the said range, the feeling which a film melt | dissolves in a mouth worsens. In addition, the higher the ratio, the more difficult it is to chew. Moreover, even if the said ratio is too much or too little, the balance with the content will worsen, and it will not be able to fully acquire the good texture when eaten.

The amount of the contents enclosed in the capsule coating is in the range of 1400 mg to 3000 mg. In order to obtain a delicious texture when the amount of the capsule film and the content is balanced, the amount of the content is preferably within the above range. If the amount of content exceeds this range, it becomes difficult to chew.

<Capsule film>

The composition of the capsule film contains gelatin, which is a film forming base, as an essential component. The gelatin may be gelatin derived from any of cows, pigs, chickens and fish. The production method may be any method such as alkali extraction or acid extraction, and the gel strength of gelatin is not limited.

It is preferable to contain glycerin as a plasticizer other than the base. The blending amount of glycerin in the capsule coating is preferably 30 to 200 parts by mass, more preferably 50 to 100 parts by mass with respect to 100 parts by mass of gelatin. Even if the blending amount of glycerin is too high or too small, the processing aptitude is poor when the capsule is molded, and a good feeling is not obtained when chewing. In addition, as the amount of glycerin blended increases, adhesion between the capsules easily occurs.

It is preferable to contain a crystal precipitation agent in the capsule film. The content of crystallization agent is preferably 1 to 200 parts by mass, more preferably 1 to 50 parts by mass with respect to 100 parts by mass of gelatin. The higher the amount of crystallization agent, the greater the feeling of cooling when the capsule is eaten, and the adhesion between the capsules does not easily occur, but too much, the processing aptitude during molding the capsule is bad.

In the chewable capsule of the present invention, it is preferable that at least a part of the crystal precipitation agent blended into the capsule film is precipitated as a crystal and exposed on the surface of the film. The state in which the precipitates of the crystal precipitates are exposed may be in a state in which the precipitates (crystals) are attached on the outer surface of the capsule film, or a part of the precipitates may be buried in the capsule film.

Preferred examples of the crystal precipitation agent include sugar alcohols such as xylitol, erythritol, trehalose and D-sorbitol. Among these, xylitol is preferable because it is excellent in properties such as crystal precipitation, cooling sensation, and sweetener.

The capsule coating can contain an appropriate amount of seasonings such as sweeteners. As the sweetener, for example, synthetic sweeteners such as sucralose, acesulfame potassium, stevia and aspartame, and sugars such as sucrose and fructose can be used.

Moreover, additives, such as a coloring agent, a copper, and a fragrance | flavor, can be contained in addition to each said component.

<Contents>

It is preferable that a content is liquid, and it is preferable that the viscosity in 25 degreeC is 2 Pa * S or less. If the viscosity is higher than this, the amount of spread (diffusion) of the contents worsens when the capsule is ingested. The preferable value of the said viscosity is about 0.5 Pa * S.

The viscosity of the contents can be adjusted by adding a thickener as necessary. The thickener is not particularly limited as long as it can be added to food. For example, beeswax, glycerin fatty acid ester, or the like can be used.

If the liquid content is a hydrophilic material, the content is likely to react with gelatin, which is the base of the capsule film, and thus changes easily over time. Therefore, the content is preferably a lipophilic material. The lipophilic substance in the present specification means a substance having lipophilic (hydrophobic) to the extent that it does not adversely affect the capsule coating based on gelatin over time.

Although the component of the content is not specifically limited, Oily substances, such as animal and vegetable oil, or its powder suspension can be used. Preferred embodiments include one or two or more selected from the group consisting of animal and vegetable oils, phospholipids and ceramides.

Specific examples of animal and vegetable oils include safflower oil, olive oil and fish oil.

Or as at least one member selected from the group consisting of monocarboxylic acids and / or derivatives thereof having 20 carbon atoms and at least one member selected from the group consisting of monoenoic acids and / or derivatives thereof having 22 carbon atoms It can be used preferably. These are known as an active ingredient of the hyperuric acid disease prophylaxis agent as an example (patent document 6). Therefore, the chewable capsule containing the above ingredients in the contents can be orally administered to humans or animals as a prophylactic agent or dietary nutritional composition for lifestyle diseases represented by hyperuric acid diseases.

Monounsaturated fatty acids and / or derivatives thereof, and the monounsaturated fatty acid and / or a derivative thereof having 22 carbon atoms in the 20 Specifically, Ikoma sensan (Eiko sensan) such as a condominium acid, gadol resan, 5-Ikoma sensan having a carbon number of 20 And / or derivatives thereof, and docosenoic acid and / or derivatives thereof such as eroxane (ercinic acid), sedorenic acid, and 5- dococenic acid having 22 carbon atoms.

The monocarboxylic acid having 20 carbon atoms and monoenoic acid having 22 carbon atoms are not particularly limited as long as they are pharmaceutically or foodly acceptable, and natural fats and oils having high content of these higher monoenoic acids such as shark liver oil and whale oil , Cod liver oil, rapeseed oil, mustard oil, cabbage seed oil, jojoba oil, meadowfoam oil, etc. may be used as it is or in combination as appropriate.

From these natural fats and oils, it is also possible to extract and purify isocenoic acid or docosenoic acid by conventional methods such as fractional distillation, crystallization, solvent extraction, urea clathrate, or chromatography. In addition, commercially available condoic acid or ermic acid (all of which are manufactured by Sigma) can be used simply.

These derivatives of higher monoenoic acid include derivatives such as various esters, in addition to higher monoenates. Specific examples thereof include salts with alkali metals such as sodium and potassium, esters with lower aliphatic alcohols such as methanol and ethanol, mono, di, and triglycerides.

The ratio of monocarboxylic acid and / or derivative thereof having 20 carbon atoms and monoenoic acid having 22 carbon atoms and / or derivative thereof has monomonic acid having 22 carbon atoms and / or 1 part by mass of the derivative thereof. And / or 0.1 to 17 parts by mass of the derivative thereof is preferable because it has a higher prevention and treatment effect of a lifestyle disease typified by hyperuric acid disease than when it is outside this range.

Effective dosages are for oral administration (as for oral administration in the diet), monoenoic acid and / or derivatives thereof with 20 carbon atoms, and monoenoic acid and / or derivatives thereof with 22 carbons (hereinafter higher mono) 5 to 400 mg / kg body weight / day, based on the amount of the active ingredient. Therefore, what is necessary is just to set content of the said higher monoenoic acid in the content enclosed in a chewable capsule so that the said effective dose can be ingested by 1 to several administrations. In particular, since the chewable capsule of the present invention can increase the amount of the contents per capsule, it is very suitable for the case of formulating by encapsulating a higher monoenoic acid having a higher intake rate for the prophylactic treatment of lifestyle diseases.

In addition, the contents of the chewable capsules may contain surfactants such as glycerin fatty acid esters and sucrose fatty acid esters, various cured oils, and lead.

Moreover, as another component, you may contain suitable additives, such as a fragrance | flavor, a sweetener, and a coloring agent. The fragrance can use various natural and synthetic fragrances according to the purpose. As the sweetener, synthetic sweeteners, sugars, sugar alcohols and the like can be used. The colorant may be a synthetic colorant, a natural colorant, or the like.

<Manufacturing method>

The chewable capsule of the present invention can be produced through a step of forming a capsule-shaped molded article using a coating material liquid containing gelatin and a drying step of drying the molded article.

The method of molding the coating material liquid containing gelatin into a capsule shape is not particularly limited, and various well-known methods can be used. For example, a method of forming a capsule coating while filling the contents using a rotary automatic soft capsule manufacturing machine described in Japanese Patent Application Laid-Open No. 10-80466 can be suitably used.

Hereinafter, an embodiment of the chewable capsule manufacturing method of the present invention will be described. 1 is a schematic view showing an example of a rotary automatic soft capsule manufacturing apparatus suitably used in the present embodiment.

First, the component of the film is dissolved in an appropriate amount of water to prepare a coating material liquid. If necessary, warm to dissolve uniformly. Since the amount of gelatin in the coating material liquid is too large or at least difficult to form, the coating material liquid is in a range that can be formed into a desired coating shape. The amount of gelatin in the coating material liquid is about 20 to 45% by mass, more preferably about 30 to 40% by mass.

On the other hand, the contents are prepared in the liquid phase separately from this.

As shown in FIG. 1, the film sheet 1 which shape | molded the film material liquid in strip | belt shape is sent out between two pieces and a pair of rotating cylindrical metal mold | die 2. As shown in FIG. While rotating the rotating cylindrical mold 2, the contents 4 are press-fitted between the two film sheets 1 to the pump 3 which interlocks with this. At this time, the said coating sheet 1 is heated by the segment 5 to the suitable temperature which can be heat-sealed, and the joint part is formed by the convex tooth and the tooth-piece | tip compression formed in the surface of the rotating cylinder die 2. (6) can be heat-sealed to obtain a capsule shaped body 7.

The method of forming the coating sheet 1 is not particularly limited, but for example, the coating liquid can be flattened into a sheet shape, and the gel-like coating sheet 1 can be formed by temperature control at a temperature at which gelatin is gelled. Can be.

Next, the obtained capsule molded body 7 is dried to produce a chewable capsule.

The drying process is first performed for 10 hours in an atmosphere in which the humidity is controlled within ± 5% and the temperature within ± 2 ° C for the first condition selected within the range of humidity 30% to 50% and the temperature 20 ° C to 30 ° C. Primary drying to dry for 12 hours is performed. It is preferable to perform primary drying using the rotary drying method. The rotation drying method herein refers to a method in which an undried capsule is placed in a hollow container (for example, a cylindrical basket) having an air permeable bottom, and the dehumidified air is sent into the container while the container is rotated to dry the capsule. Specifically, it can perform suitably using the rotary blow dryer provided with a container, the means to rotate the said container, and a blowing means.

After primary drying, aging is carried out for 2 hours to 3 hours in a controlled atmosphere within a humidity range of 70% ± 5% and a temperature of 25 ° C ± 2 ° C. It is preferable to perform aging in the state which fixed the capsule. More preferable aging time is about 3 hours.

After aging, for a second condition selected within a range of 30% to 50% humidity and a temperature of 20 ° C to 30 ° C, 35 to 70 hours in an atmosphere in which the humidity is controlled to within ± 5% and the temperature within ± 2 ° C. By performing secondary drying to dry, the chewable capsule is completed. More preferable drying time is about 40 to 60 hours. It is preferable to perform secondary drying by the rotary drying method similarly to primary drying.

Immediately after the secondary drying, the water content of the capsule coating is preferably about 10 to 20% by mass due to the problem of chewing and magnetostriction. A more preferable range is 13-17 mass%. In addition, the water content of a capsule film can be measured by a drying weight loss method.

According to the production method of the present embodiment, a large, thin film is soft, and even if the amount of the content is large, it is possible to prevent deformation of the own weight or destruction of the weight, so that the chewable capsule according to the present invention can be produced in a good yield.

Specifically, a conventional general internal soft capsule is usually molded into a capsule shape, and then dried in a humidity of 30% to 50% and a temperature of about 20 to 30 ° C. using a rotary blow dryer for about 20 hours. On the other hand, the chewable capsules according to the present invention are typically formed with a thinner (lower ratio of the film) of the capsule film so that the outer diameter is significantly larger and heavier than the internal capsule. For this reason, when it is going to manufacture the chewable capsule which concerns on this invention by the method of finishing by one conventional drying process, a capsule will split by self weight during rotation drying.

In this embodiment, the temperature and humidity at the time of primary drying and secondary drying are strictly managed (temperature control ± 2 ° C, humidity control ± 5%), and during this time, aging under high humidity (about 70% humidity) Is done. According to this method, it is possible to prevent the capsule from deforming or cracking during rotational drying. Moreover, crystallization by the crystal precipitation agent contained in a coating material liquid precipitates efficiently by carrying out aging on the said conditions. In addition, in order to deposit the crystals of xylitol (crystal precipitant) uniformly on the capsule surface, the drying rate must be strictly controlled. According to this embodiment, a chewable capsule having a homogeneous quality in which crystals are uniformly precipitated is Obtained.

1 is a schematic view showing an example of a rotary soft capsule charger suitably used in an embodiment according to the present invention.

Hereinafter, although an Example is shown and this invention is demonstrated further more concretely, this invention is not limited to a following example.

Example 1

<Preparation of capsule contents>

(a) Main raw cod liver oil: 100 parts by mass, (b) Thickener beeswax (manufactured by Cerarica NODA Co., Ltd.): 5.4 parts by mass, (c) Flavored orange fragrance (manufactured by Hasegawa Inc.): 2.2 parts by mass, (d) Flavor 1 Menthol (produced by Kobayashi Kay Co., Ltd.): 0.2 parts by mass, (e) sweetener sucralose (manufactured by San-Eigen FFI Co., Ltd.): 0.1 parts by mass, (f) colorant β-carotene (30%) (san-eigen FFI Co., Ltd.) Product): 0.02 parts by mass

First, (a) was heated at about 70 degreeC, (b) was added, and it melt | dissolved. After cooling this to 30 degrees C or less, (c), (d), (e), and (f) were added and stirred. Thereafter, the mixture was ground and emulsified in a colloid mill, degassed under reduced pressure, and a uniform solution was obtained. The viscosity of the solution (contents) thus obtained was 1.5 Pa · s at 25 ° C.

<Preparation of capsule coating material liquid>

(a) gelatin (product made from Niffy Gelatin Industries, Ltd. (gelatin derived from bone, l65-185)): 100 parts by mass, (b) glycerin: 70 parts by mass, (c) erythritol (manufactured by Mitsubishi Chemical Foods Corporation): 10 parts by mass (d) Xylitol (product of Towa Kasei Co., Ltd .: xylite): 3.5 parts by mass, (e) sucralose (product of San-Eigen FFI Corporation): 2 parts by mass, (f) water: 90 parts by mass

After stirring and dissolving (a)-(f) at about 70 degreeC, heating, the solution was vacuum-degassed and filtered to make it a uniform solution (capsule film material liquid).

Manufacture of capsules

The contents prepared above and the capsule coating material liquid were applied to a rotary soft capsule filling machine to form a spherical capsule molded body having a mass of the capsule content of 1500 mg.

This was immediately dried for 10 hours using a rotary blow dryer in an air atmosphere at a temperature of 25 ° C. at a humidity of 50% (primary drying). Humidity was maintained in 50% +/- 5% of range, and temperature was controlled to maintain in 25 degreeC +/- 2 degreeC. In addition, the rotation speed of the rotary blow dryer was 10 rpm.

Next, it was left standing for 3 hours in an air atmosphere at a temperature of 25 ° C. at a humidity of 70% (aging). Humidity was kept in the range of 70% +/- 5%, and temperature was controlled to keep it in the range of 25 degreeC +/- 2 degreeC.

A spherical chewable capsule was then obtained by drying (secondary drying) for 35 hours using a rotary blow dryer in an air atmosphere at a temperature of 25 ° C. at a humidity of 50%. Humidity was maintained in 50% +/- 5% of range, and temperature was controlled to maintain in 25 degreeC +/- 2 degreeC. In addition, the rotational speed of the rotary blow dryer was 15 rpm. The moisture content of the capsule film immediately after finishing secondary drying was 14 mass%.

The outer diameter (caliber diameter) of the film of the chewable capsule (spherical chewable soft capsule) thus obtained was 16 mm, the total capsule weight was 1750 mg, and the capsule film mass was 250 mg (about 14.3% of the total capsule mass).

In this embodiment, no deformation or self-destruction of the capsule occurred during rotational drying. The outer surface of the chewable capsule thus obtained was a high quality capsule in which crystals of xylitol were uniformly precipitated.

Example 2

<Preparation of capsule contents>

(a) Main raw material DHA-containing fish oil: 100 parts by mass, (b) Thickener beeswax (product of Serera NODA Co., Ltd.): 2.5 parts by mass, (c) Flavored lemon fragrance (manufactured by Takasago Inc.): 2.5 parts by mass, (d) Sweetener aspartame (product of Ajinomoto Co., Ltd.): 0.1 parts by mass, (e) colorant β-carotene (30%) (product of San-Eigen FFI Co., Ltd.): 0.02 parts by mass

First, (a) was heated at about 70 degreeC, (b) was added, and it melt | dissolved. After cooling this to 30 degrees C or less, (c), (d) and (e) were added and stirred. Thereafter, the mixture was ground and emulsified with a colloid mill, degassed under reduced pressure, and a uniform solution was obtained. The viscosity of the solution (contents) thus obtained was 1.5 Pa · s at 25 ° C.

<Capsule coating material liquid preparation>

(a) Gelatin (Gelatin Co., Ltd. (gelatin derived from pork skin, Broom 190-220)): 100 parts by mass, (b) Glycerin: 150 parts by mass, (c) Trehalose (manufactured by Hayashibara Corporation): 10 parts by mass, ( d) Xylitol (Towa Kasei Co., Ltd. product: xylite): 100 parts by mass, (e) water: 90 parts by mass

After stirring and dissolving (a)-(e) about 70 degreeC, heating, the solution was vacuum degassed and filtered to make it a uniform solution (capsule film material liquid).

Manufacture of capsules

Using the contents prepared above and the capsule coating material solution, a capsule molded article having a mass of the capsule contents of 3000 mg was formed in the same manner as in Example 1.

This was immediately done in the same manner as in Example 1 to prepare a chewable capsule (spherical chewable soft capsule). The moisture content of the capsule film immediately after finishing secondary drying was 14 mass%.

The outer diameter (caliber) of the chewable capsule coating thus obtained was 20 mm, the total capsule mass was 3600 mg, and the capsule coating mass was 600 mg (about 16.7% of the total capsule mass). During the manufacturing process, the capsules did not cause magnetism, self-destruction, and were very high quality capsules in which crystals of xylitol were uniformly deposited on the capsule surface.

 <Test Example>

Next, a test example is shown.

Test Example 1

In Test Example 1, a chewable capsule sample was prepared in the same manner as in Example 1 except that the outer diameter (caliber) of the capsule coating was changed within the range of 10 to 30 mm as shown in Table 1 below. Moreover, the film ratio was unified to 15% by changing the quantity of content according to the change of aperture.

The sensory test was done about the obtained sample. The sensory test was conducted by 20 panelists who sampled each sample, and scored the following evaluation criteria by the scoring method about three items which are easy to eat, easy to chew, and diffusibility of the contents.

The results are shown in Table 1. The evaluation result of each test item by 20 panels was shown by the mean value + standard deviation. For each test item, statistical analysis using Fisher's PLSD method as variance analysis and post-hoc test was performed, and statistically significant evaluations other than "normal" or less ("bad") were compared with other test groups. It performed appropriately. In addition, it means that there is a statistically significant difference between the different characters in the superscript alphabet attached to the numerical values of Table 1.

Sample No. (Capsule diameter) Mass of contents (mg) Test Items Easy to eat Easy to chew Diffusion of contents Sample 1 (10mm) 1100 5.0 ± 0.9 ^a 2.1 ± 0.8 ^a 1.9 ± 0.8 ^a Sample 2 (14mm) 1400 9.9 ± 0.5 ^b 7.3 ± 1.0 ^b 6.9 ± 0.9 ^b Sample 3 (20mm) 2200 9.8 ± 0.8 ^b 9.0 ± 1.0 ^c 8.8 ± 1.0 ^c Sample 4 (25mm) 3000 7.3 ± 0.8 ^c 5.4 ± 1.l ^d 6.8 ± 0.8 ^b Sample 5 (30mm) 4500 1.9 ± 0.6 ^d 1.9 ± 0.6 ^a 1.9 ± 0.6 ^a

From the results in Table 1, good results were obtained in both the ease of eating, the ease of chewing, and the diffusibility in the mouth of the capsule, in the range of 14 mm to 25 mm in the outer diameter of the capsule coating and in the range of 1400 mg to 3000 mg in the capsule content mass. I could know Jim.

<Test Example 2>

As shown in Table 2 and Table 3, a chewable capsule was prepared in the same manner as in Example 1 except that the capsule coating ratio was changed to a range of 8% to 25%. In addition, the outer diameter (diameter) of the capsule film was unified to 20 mm, the total mass of the capsule was unified to 3600 mg, and the value of the film rate was controlled by changing the film thickness and the content of the capsule film. The sensory test was done about the obtained sample by the method similar to the test example 1. In the sensory test, 20 panelists each tried and evaluated three items, such as the ease of chewing, the degree to which the film melts in the mouth, and the amount of contents, in the same manner as in Test Example 1. The results are shown in Table 2 below.

The stability test was performed on the following three items.

(1) Breakdown strength test: Dropped 10 capsules to the floor at a height of 1 m, and from the degree of breakage of the capsule surface (degree of penetration), the product was "very good" and "slightly deformed, but good as a product ( ○) ”or“ defect (×) ”.

(2) Storage test at high temperature: 10 capsules of capsules were stored in a 40 degreeC thermostat for 1 week, and the state of the capsule was observed. As a result, the case where the capsule surface is dried and there is no adhesion between capsules is "no adhesion between capsules (◎)", and the case where the crystallization is slightly reduced is "it can be easily attached by hand (○)". In the case where the capsules were bonded together, they were attached to each other and could not be attached by hand (×).

(3) Cycle test: After repeating three cycles of storage at 40 ° C. and storage at 5 ° C. for 24 hours each, the adhesion of capsules and the like were observed. Observation results indicate that the capsule surface is dry and there is no adhesion between the capsules (`` no adherence between capsules ''), and that the crystallization site is slightly reduced. The case where the capsules adhered was set to "it was attached and could not be removed by hand (x)".

Table 3 shows the results of these stability tests.

Sample No. (Rate of film) Test Items Easy to chew The degree to which the film melts in the mouth Degree of contents Sample 6 (8%) 8.9 ± 0.7 ^a 8.9 ± 0.8 ^a 1.4 ± 0.5 ^a Sample 7 (10%) 8.6 ± 0.9 ^a 8.6 ± 1.0 ^a 7.8 ± 0.8 ^b Sample 8 (15%) 8.8 ± 1.0 ^a 8.7 ± 1.2 ^a 8.8 ± 1.1 ^c Sample 9 (20%) 6.7 ± 0.9 ^b 6.7 ± 0.9 ^b 7.4 ± 0.8 ^b Sample 10 (25%) 5.2 ± 1.0 ^c 1.7 ± 0.5 ^c 1.7 ± 0.5 ^a

Sample No. (Rate of film) Test Items Breaking strength Store at high temperatures Cycle test Sample 6 (8%)  ×  ×  × Sample 7 (10%)  ○  ○  ○ Sample 8 (15%)  ◎  ◎  ◎ Sample 9 (20%)  ◎  ◎  ◎ Sample 10 (25%)  ◎  ◎  ◎

From the results of Table 2 and Table 3, it is easy to chew when the capsule coating rate is in the range of 10 to 20%, and the texture of the coating melts in the mouth, the amount of the contents, and the stability of the external force or environmental change to the capsule. It turned out to be compatible.

<Test Example 3>

The following test was done about the preferable compounding ratio range of glycerin and xylitol in a gelatin film. That is, as shown in the following Table 4, the compounding quantity of glycerin with respect to 100 mass parts of gelatin was changed within the range of 20-250 mass parts, and the chewable capsule was produced like Example 1 except others. At this time, the compounding quantity of glycerin was unified at 10 mass parts with respect to 100 mass parts of gelatin.

In addition, as shown in Table 5 below, the compounding amount of xylitol to the mass part of gelatin 100 was changed within the range of 0.5 to 250 parts by mass, and the chewable capsule was prepared in the same manner as in Example 1. At this time, the compounding quantity of glycerin was unified to 60 mass parts with respect to 100 mass parts of gelatin.

The sensory test and the quality judgment test were done about the obtained sample. In the sensory test, 20 panelists sampled each sample, and the same evaluation as Test Example 1 was performed regarding the degree of chewing feeling with respect to the sample which differs in the amount of glycerin, and the degree of cooling feeling with respect to the sample which differs in the amount of xylitol. .

Quality judgment tests were evaluated for workability and mutual adhesion.

(4) The processing aptitude is comprehensively evaluated for ease of actual capsule molding from ① ease of casting (forming of the sheet for forming capsule), ② ease of peeling from the casting drum of the cast film sheet, and ③ ease of heat sealing. did. All of the above ① to ③ are aptitude (very good), the one item is not aptitude good (○), the two items are not aptitude "slightly bad (△) And "all are not aptitudes" as "bad (x)".

(5) Mutual adhesiveness was stored for one week at 40 ° C, and the appearance as a product was evaluated from the adhesive surface state of the capsules. `` Very good (◎) '' when the capsule surface is dried and there is no adhesion between the capsules. `` Good '' when the capsule surface is not dried but without the adhesion between capsules. This slight increase and gloss were observed, but the case where no adhesion between the capsules was "normal (Δ)" and the case where the capsules were adhered even slightly was set as "bad (x)".

 Sample No (Glycerin Blended Amount)  Test Items  Processing aptitude  Chewing  Mutual attachment  Sample 11 (20) △ 1.6 ± 0.7 ^a ◎  Sample 12 (30) ○ 5.4 ± 0.8 ^b ◎  Sample 13 (60) ◎ 6.6 ± 0.9 ^c ○  Sample 14 (100) ○ 9.0 ± 0.8 ^d △  Sample 15 (200) ○ 8.9 ± 0.8 ^d △  Sample 16 (250) × 6.6 ± 0.6 ^c ×

  Sample No (Xylitol Compounding Amount)  Test Items  Processing aptitude Refreshing feeling  Mutual attachment Sample 17 (0.5) ◎ 1.5 ± 0.5 ^a × Sample 18 (1) ◎ 7.1 ± 0.8 ^b △ Sample 19 (10) ◎ 7.0 ± 1.0 ^b ○  Sample 20 (100) ◎ 9.0 ± 0.7 ^c ◎  Sample 21 (200) ○ 8.7 ± 0.7 ^c ◎ Sample 22 (250) × 9.0 ± 0.7 ^c ◎

From the result of Table 4 and Table 5, the favorable result was obtained with 30-200 mass parts of compounding quantities of glycerin, and 1-200 mass part of xylitol compounding quantities.

Test Example 4

In the contents composition shown in Example 1, the viscosity at 25 ° C. of the contents was changed by changing the compounding amount of beeswax (thickener) to 0.1, 0.5, 1.0, 2.0, 2.5, 3.0 Pa · s as shown in Table 6 below. The chewable capsule was prepared in the same manner as in Example 1 except for changing to 6 steps. The sensory test was done about the obtained sample. In the sensory test, 20 panelists sampled each sample and carried out by the same evaluation method as Test Example 1 about the degree to which content spreads easily in a mouth (diffusion). The results are shown in Table 6 below.

Sample No (viscosity unit: Pas)  Test Items Diffuseness in the mouth  Sample 23 (0.1) 9.0 ± 0.7 ^a  Sample 24 (0.5) 9.2 ± 0.7 ^a  Sample 25 (1.0) 8.9 ± 0.7 ^a  Sample 26 (2.0) 6.9 ± 0.9 ^b  Sample 27 (2.5) 4.8 ± 0.8 ^c Sample 28 (3.0) 1.6 ± 0.5 ^d

From the result of Table 6, it turned out that favorable diffusivity is obtained when the viscosity in the content of 25 degreeC is 2.0 Pa * s or less.

Test Example 5

In order to examine the preferred drying conditions in the preparation of the chewable capsule, the mass of the contents of the capsule in Example 1 was changed in six steps of 1,000 mg, 1,400 mg, 2,000 mg, 2,500 mg, 3,000 mg, and 3,500 mg, A chewable capsule was prepared by changing the drying method to five capsules of each size. In addition, the rotary blower was used for drying, and the rotation speed was 10 rpm.

Drying method 1: Conventional soft capsule drying method (humidity 30-50%, temperature 20-30 degreeC, drying time 20 hours)

Drying method 2: Drying method (humidity 30-50%, temperature 20-30 degreeC, drying time 45 hours) which extended the drying time in the conventional soft capsule drying method.

Drying method 3: The drying method which divided drying into two in drying method 2, and put it in between (humidity 40 ± 5%, temperature 25 ± 2 degreeC, drying time 45 hours)

Drying method 4: The drying method which divided into 2 dryings in drying method 2, and put maturation between them (primary drying with humidity 30-50%, temperature 20-30 degreeC, drying time 10 hours, and then at 70% humidity) Aged for 3 hours, and then again dried for 35 hours under the same conditions as the first drying)

Drying method 5: Drying method (strict humidity 40 ± 5%, temperature 25 ± 2 ° C., drying time 10 hours, primary drying at 3 hours at 70 ± 5% other humidity) And then again dry for 35 hours under the same conditions as the first drying)

Drying method 6: It is dried for 5 hours at 30% of humidity and temperature of 31 degreeC, and then left for 3 hours at 80% of humidity and temperature of 28 degreeC, and then it is dried for 12 hours at humidity of 30% and temperature of 31 degreeC.

The obtained sample was comprehensively evaluated for the self-weight deformation of the capsule, the self-weight breakdown, and the precipitation state of the xylitol crystals. All of the above evaluation items have no problem as a product in "◎", and the above evaluation items have no problem as a product, but "○" means that there is a problem in one item. "(Triangle | delta)" which has a problem with an item | item, and any thing which has a problem as a product even in one of the said items was made into "x". In the evaluation item, it was judged to be appropriate as a product other than "x".

 Test Items  Drying method 1  Drying Method 2  Drying Method 3  Drying Method 4  Drying Method 5  Drying Method 6  Sample 29 (1, OOO mg)  ×  ×  △  ○  ◎  ○  Sample 30 (1,400 mg)  ×  ×  △  ○  ◎  △  Sample 31 (2,000 mg)  ×  ×  ×  △  ◎  ×  Sample 32 (2,500 mg)  ×  ×  ×  △  ◎  ×  Sample 33 (3,000 mg)  ×  ×  ×  ×  ○  ×  Sample 34 (3,500 mg)  ×  ×  ×  ×  △  ×

According to the drying method 5 from the result of Table 7, the mastic capsule can be manufactured without the self weight deformation and the self weight destruction up to 3,000 mg, and the good capsule which the crystal of xylitol was uniformly deposited on the capsule surface Obtained.

The present invention is suitable for chewable capsules, so-called chewable soft capsules used in foods, especially health foods, certain health foods, pharmaceuticals, quasi-drugs, and the like, and methods for producing the same.

Claims (7)

A capsule film and the contents enclosed in the capsule film, The outer diameter of the capsule film is 14 mm to 25 mm, The mass of the capsule coating is in the range of 10% to 20% of the total mass of the chewable capsule, The amount of the contents enclosed in the capsule film is 1400mg to 3000mg, Chewable capsule containing gelatin in the capsule film. The chewable capsule according to claim 1, wherein the capsule coating contains 30 to 200 parts by mass of glycerin and 1 to 200 parts by mass of a crystal precipitation agent with respect to 100 parts by mass of gelatin. The chewable capsule according to claim 2, wherein at least a part of the crystal precipitation agent is exposed to the surface of the film as a crystal. The chewable capsule according to any one of claims 1 to 3, wherein the content is a liquid lipophilic substance having a viscosity of 2 Pa · s or less at 25 ° C. 5. The chewable capsule according to claim 4, wherein the contents contain one or two or more selected from the group consisting of animal and vegetable oils, phospholipids and ceramides. The method according to claim 4, wherein the contents are at least one selected from the group consisting of monocarboxylic acids having 20 carbon atoms and / or derivatives thereof, and at least one member selected from the group consisting of monoenoic acids having 22 carbon atoms and / or derivatives thereof. A chewable capsule containing the above. A step of forming a capsule-shaped molded article using a coating material liquid containing gelatin, and a drying step of drying the molded article, In the drying process, for a first condition selected within a range of 30% to 50% humidity and a temperature of 20 ° C to 30 ° C, the humidity is within ± 5% and the temperature is within ± 2 ° C for 10 hours to a controlled atmosphere. Primary drying for 12 hours, After the first drying, aging for 2 hours to 3 hours in a controlled atmosphere in the range of humidity 70% ± 5%, temperature 25 ℃ ± 2 ℃, After the aging, for a second condition selected within a range of 30% to 50% humidity and a temperature of 20 ° C to 30 ° C, the humidity is within ± 5% and the temperature is within 35 hours to 70 ° C under a controlled atmosphere. A method of making the chewable capsule of claim 1, wherein the second drying is carried out for a time.

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